Stop guessing which predicates to cite. Veridocx analyzes 180,000+ cleared devices to surface the strongest matches—with complete FDA citations and audit-ready documentation.
Supported by leading programs
The average 510(k) submission takes 6-12 months and costs $31,000+ in regulatory consulting fees.
Most of that time isn't spent on strategy. It's spent on systematic research—searching 180,000+ cleared devices, comparing specifications, and mapping standards.
Work that's predictable. Tedious. And ripe for automation.
The Substantial Equivalence (SE) matrix is the heart of your 510(k). Veridocx automates the comparison across indications, technological characteristics, and performance specifications—grounded in complete FDA citations.
Compare indications and tech specs in seconds, not days.
Every data point is linked directly to the source FDA summary.
Export tables directly into your FDA submission templates.
Regulatory professionals need evidence, not black-box AI. Veridocx is engineered to meet the same standards of rigor your team applies to every FDA submission.
Learn about our methodologyGreat. Use Veridocx first.
| What You Need | Submission Tools | Veridocx |
|---|---|---|
| Find optimal predicates | Manual search | AI-ranked |
| Generate SE comparison | Write yourself | Automated |
| Identify testing gaps | Not offered | With standards |
| Fill eSTAR form | Core feature | Coming soon |
Expert analysis on 510(k) logic, FDA pathway selection, and the engineering of substantial equivalence.
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Most people assume regulatory work is slow because the rules are hard.
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Join regulatory teams already using Veridocx to streamline predicate research and gap analysis.
Direct intelligence on regulatory markers and FDA decision metrics.